cibinqo

Generic: abrocitinib

Labeler: u.s. pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cibinqo
Generic Name abrocitinib
Labeler u.s. pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

abrocitinib 50 mg/1

Manufacturer
U.S. Pharmaceuticals

Identifiers & Regulatory

Product NDC 63539-236
Product ID 63539-236_0043f6db-decd-4d53-a301-35f2f7a63664
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213871
Listing Expiration 2026-12-31
Marketing Start 2022-02-24

Pharmacologic Class

Established (EPC)
janus kinase inhibitor [epc]
Mechanism of Action
janus kinase inhibitors [moa] p-glycoprotein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63539236
Hyphenated Format 63539-236

Supplemental Identifiers

RxCUI
2591481 2591487 2591489 2591491 2591493 2591495
UNII
73SM5SF3OR
NUI
N0000190858 N0000190857 N0000185503

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cibinqo (source: ndc)
Generic Name abrocitinib (source: ndc)
Application Number NDA213871 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 14 TABLET, FILM COATED in 1 BOTTLE (63539-236-14)
source: ndc

Packages (1)

63539-236-14 14 TABLET, FILM COATED in 1 BOTTLE (63539-236-14)

Ingredients (1)

abrocitinib (50 mg/1)

Linked Drug Pages (1)

CIBINQO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0043f6db-decd-4d53-a301-35f2f7a63664", "openfda": {"nui": ["N0000190858", "N0000190857", "N0000185503"], "unii": ["73SM5SF3OR"], "rxcui": ["2591481", "2591487", "2591489", "2591491", "2591493", "2591495"], "spl_set_id": ["16c12a56-4550-414b-ac9d-b785b41fea6b"], "pharm_class_epc": ["Janus Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Janus Kinase Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["U.S. Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "14 TABLET, FILM COATED in 1 BOTTLE (63539-236-14)", "package_ndc": "63539-236-14", "marketing_start_date": "20220224"}], "brand_name": "CIBINQO", "product_id": "63539-236_0043f6db-decd-4d53-a301-35f2f7a63664", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Janus Kinase Inhibitor [EPC]", "Janus Kinase Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "63539-236", "generic_name": "abrocitinib", "labeler_name": "U.S. Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CIBINQO", "active_ingredients": [{"name": "ABROCITINIB", "strength": "50 mg/1"}], "application_number": "NDA213871", "marketing_category": "NDA", "marketing_start_date": "20220224", "listing_expiration_date": "20261231"}